Return to List

Study Summary
No. 2005-0917:.......Advanced Cancers; Endocrine; Gastrointestinal; Kidney; Pediatrics; Peritoneum; Phase I Studies......Andrea Hayes-Jordan......Pediatrics
.
Study Summary Title
Study Summary
Number:
2005-0917
Study Title:A Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Doses of Cisplatin for Children with Peritoneal Carcinomatosis or Advanced Peritoneal and Retroperitoneal Disease
.
Physician New Patient Referral
Name:Andrea Hayes-JordanPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:PediatricsReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6620
Contact us about clinical trials
.
General Information
Disease Group:Advanced Cancers
Endocrine
Gastrointestinal
Kidney
Pediatrics
Peritoneum
Phase I Studies
Supported By:N/A
Phase of Study:Phase IReturn
Visit:
Patients must return, one week, one month, three months, six months and nine
months after discharge.
Treatment
Agents:
Cisplatin
Surgical Procedure
Home Care:None
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Two to three day ICU stay and estimated 14 days in hospital.
Description/
Intervention:
The goal of this research study is to find the highest tolerable dose of
cisplatin given to pediatric patients undergoing extensive surgery to remove
all visible tumor from the abdominal cavity.
.
Study Objectives / Outcomes
There has been no successful treatment of diffuse peritoneal metastasis or carcinomatosis, in childhood tumors. Once this advanced stage of disease is evident, survival is measured in weeks. The selective lethal effect of supranormal temperatures on neoplastic cells and the additive or synergistic effect of combining chemotherapy has been well established in adult clinical trials using continuous hyperthermic peritoneal perfusion (CHPP) for advanced peritoneal adenocarcinoma of gastrointestinal origin, ovarian carcinoma and mesothelioma.

This phase I study will evaluate the safety of continuous hyperthermic peritoneal perfusion with escalating
doses of intraperitoneal cisplatin in the treatment of children with refractory tumors limited to the
abdominal cavity. If tumors are outside the abdominal cavity, the tumors must be able to be controlled.
Since CHPP has potential to improve outcome of children with peritoneal and retroperitoneal metastases,
this study will evaluate the safety of elevated temperature (40oC) with intraperitoneal cisplatin chemotherapy.

Primary
1. To determine the MTD and dose-limiting toxicity of intraperitoneal cisplatin given in combination with CHPP as a 90 minute perfusion in children with advanced peritoneal and retroperitoneal solid tumors
2. To determine the safe and tolerable dose of CHPP with cisplatin to be used in Phase II trials
3. To determine the pharmacokinetics of intraperitoneal cisplatin platinum given with CHPP as a 90 minute abdominal perfusion (Optional)
.
Study Status Information
Study Activation / Registration Date:02/13/2007
IRB Review and Approval Date:09/20/2006
Study Type:Phase I
Recruitment Status:Terminated
Projected Accrual:N/A
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Age greater than or equal to 3 and less than or equal to 18 years

2) Histologically proven diffuse peritoneal or retroperitoneal tumor from the following histologies: adenocarcinoma of the gastrointestinal tract, desmoplastic round cell tumor, late stage neuroblastoma, ovarian germ cell, sarcoma, adrenocorticocarcinoma, Wilms', rhabdomyosarcoma. (target groups: desmoplastic small round cell tumor (DSRCT), neuroblastoma, and recurrent tumors). If tumors are outside the abdominal cavity, the tumors must be controllable.

3) All patients must have refractory or recurrent tumors with no known curative treatment options.

4) Radiologic workup must demonstrate that the disease is confined to the abdominal cavity. If tumors are outside the abdominal cavity, the tumors must be able to be controlled.

5) Radiologic workup or prior abdominal exploration must be consistent with disease which can be debulked to a residual size of less than or equal to1 mm thickness per tumor deposit

6) Patients must have minimum expected duration of survival of greater than 6 weeks

7) Patients must not have any systemic illness which precludes them from being an operative candidate. This includes but is not limited to sepsis, liver failure, pregnancy, lacatating females.

8) Patients must have fully intact mental status and normal neurologic abilities.

9) Patients must have adequate renal function (serum creatinine </= 1.5 without history dialysis or renal failure)

10) Patients will be eligible if the WBC is > or =2,000/ul or ANC is > or =1,500, or platelets are > or = 100,000/mm^3

11) Patients will be eligible if serum total bilirubin and liver enzymes (ALT or AST) are </= 2 times the upper limit of normal

12) Patients must be recovered from any toxicity from all prior chemotherapy, immunotherapy, or radiotherapy and be at least 14 days past the date of their last treatment

13) If tumors are outside the abdominal cavity, the tumors must be controllable.

Exclusion Criteria:1) Patients who have failed previous continuous hyperthermic intraperitoneal perfusion with platinum therapy will be ineligible

2) Patients with tumors that are unable to be controlled outside the abdominal cavity will be ineligible

3) Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure

4) Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater (because of the potential neurotoxicity associated with platinum)

.
Links
Registration Number: NCT00436657
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
.
Results


Return to Clinical Trials at M.D. Anderson Cancer Center